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Fiber Health Benefits

NCT ID: NCT02177864

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-06-30

Brief Summary

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The investigators hypothesize that fiber supplementation will provide measurable differences in indices of children's health (fewer complaints of abdominal pain and constipation, lower body mass index) compared to placebo.

Detailed Description

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This prospective study proposes supplementing children with fiber or placebo for four months. Children in elementary school, ages 5-12, will be randomized to receive fiber supplemented bars vs low-fiber snack bars (placebo).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fiber

Group Type EXPERIMENTAL

Fiber

Intervention Type DIETARY_SUPPLEMENT

Placebo

Group Type PLACEBO_COMPARATOR

Placebo (low fiber bar)

Intervention Type OTHER

Interventions

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Fiber

Intervention Type DIETARY_SUPPLEMENT

Placebo (low fiber bar)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

-Children bewteen ages of 5-12 years

Exclusion Criteria

* History of allergy/intolerance to components of the snack bars (e.g. celiac disease)
* History of Hisrchsprungs disease, abdominal surgery to intestine or colon
* Unable to take a fiber bar by mouth
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Warren Bishop

OTHER

Sponsor Role lead

Responsible Party

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Warren Bishop

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Warren Bishop, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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201202731

Identifier Type: -

Identifier Source: org_study_id